Biphasic Insulin Aspart 30 in Type 2 Diabetes Failing OAD Therapy

Completed · Phase 3

Conditions studied: Diabetes, Diabetes Mellitus, Type 2

In brief

This trial is conducted in the United States of America (USA). The aim of this trial is to compare biphasic insulin aspart 30 plus metformin in a standard injection regimen to a standard dosing of insulin glargine plus metformin on blood glucose control in subjects with type 2 diabetes who are insulin naive and failing OAD therapy.

Key facts

Study ID

NCT00598793

Run by

Novo Nordisk A/S

People needed

242

Starts

2002-11-01

Expected to finish

2004-03-01

Last updated by the study team

2017-01-09

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Insulin naive Type 2 diabetes
• Currently treated with OADs alone or combined with other treatment for at least 3 months
• BMI below 40 kg/m2 and body weight below 125 kg
• HbA1c greater than or equal to 8%

You may not qualify if…

• Inability to tolerate metformin or contradictions to its use
• Pregnant, breastfeeding or intention of becoming pregnant
• Allergy to any of the trial products
• Inability or unwillingness to perform SMBG

Where it is running

• Novo Nordisk Investigational Site — Concord, California, United States
• Novo Nordisk Investigational Site — Los Angeles, California, United States
• Novo Nordisk Investigational Site — Walnut Creek, California, United States
• Novo Nordisk Investigational Site — Melbourne, Florida, United States
• Novo Nordisk Investigational Site — Melbourne, Florida, United States
• Novo Nordisk Investigational Site — West Palm Beach, Florida, United States
• Novo Nordisk Investigational Site — Atlanta, Georgia, United States
• Novo Nordisk Investigational Site — Marietta, Georgia, United States
• Novo Nordisk Investigational Site — Idaho Falls, Idaho, United States
• Novo Nordisk Investigational Site — Chicago, Illinois, United States
• Novo Nordisk Investigational Site — Lexington, Kentucky, United States
• Novo Nordisk Investigational Site — Buffalo, New York, United States
• Novo Nordisk Investigational Site — Asheville, North Carolina, United States
• Novo Nordisk Investigational Site — Canton, Ohio, United States
• Novo Nordisk Investigational Site — Columbus, Ohio, United States
• Novo Nordisk Investigational Site — Medford, Oregon, United States
• Novo Nordisk Investigational Site — Hershey, Pennsylvania, United States
• Novo Nordisk Investigational Site — Greer, South Carolina, United States
• Novo Nordisk Investigational Site — Dallas, Texas, United States
• Novo Nordisk Investigational Site — Dallas, Texas, United States
• Novo Nordisk Investigational Site — Dallas, Texas, United States
• Novo Nordisk Investigational Site — Dallas, Texas, United States
• Novo Nordisk Investigational Site — Houston, Texas, United States
• Novo Nordisk Investigational Site — Midland, Texas, United States
• Novo Nordisk Investigational Site — San Antonio, Texas, United States

Full record on ClinicalTrials.gov

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